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Nutri-Bébé 2013 Survey on Food Consumption of Infants and Young Children (NBB2013)

26. oktober 2017 oppdatert av: Secteur Français des Aliments de l'Enfance

The French National Survey on Food Consumption of Children Under 3 Years of Age

The Nutri-Bébé 2013 survey is an observational cross-sectional study aiming to update food consumption, practices and nutrient intakes in children under 3 years of age in metropolitan France.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

Nutri-Bébé 2013 is the 5th edition of a survey conducted every 8 years since 1981 by the SFAE. The Nutri-Bébé 2013 survey is an observational cross-sectional study conducted in children living in France aged 15 days to 35 months by an official polling institute, the TNS Sofres according to the guidelines laid down in the Declaration of Helsinki. TNS Sofres fulfills the following standards and industry requirements (ESOMAR professional code of conduct and standards, ISO 20252:2012 international standard for market, opinion and social research, French data protection act (loi "informatique et libertés "). TNS Sofres ensures to conduct the surveys in accordance with the regulation on personal data protection and that respondents' personal identity is withheld. Moreover TNS Sofres appointed a data protection officer, the "Correspondant Informatique et Libertés", who is the point of contact between the "Commission Nationale de l'Informatique et des Libertés" (CNIL), the French data protection authority) and the company. The company is thus exempted, of the notification process to the CNIL. Given the type of survey conducted, namely a survey of consumption, and the characteristics developed above, the study does not require any opinion of the ethics committee.

The survey includes a section on eating behaviours and a section on food consumption.

After giving their informed consent, parents had to record the food consumption during 3 non-consecutive days (2 week days and one weekend day)framed by two face-to-face interviews,. A second visit occurred seven days later to verify and complete the diary if necessary, and conduct a face-to-face interview with the mother about eating habits over the survey period. Both interviews were recorded using CAPI® software (Computer Assisted Personal Interviews, http://www.soft-concept.com). During this visit, the child was weighed (naked, with a clean diaper or underwear) using a Tefal PREMISS PP1000VO scale with a precision of 100 g.

The child's food consumption diary was completed between the two visits of the TNS Sofres investigator. The person in charge of the child was trained to qualitatively and quantitatively report all liquid and solid foods consumed and all drinks, by specifying the exact name of the product, its potential trademark or whether it was "homemade". The type of water consumed was noted as being either "bottled" or "tap". The type (breakfast, morning snack, lunch, afternoon snack, dinner, nocturnal food intake) and timing of food consumption were collected. If applicable, vitamin, mineral or medicine supplements were noted. During the second visit the investigator reviewed thoroughly the record with the caregiver and checked the way of reporting the quantities as well as the interpretation of the photographic tool kit in order to be as close as possible to reality.

Studietype

Observasjonsmessig

Registrering (Faktiske)

1192

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Montrouge, Frankrike, 92129
        • EMERY Yves

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

The present survey is based on a randomly selected sample with socio-demographic characteristics similar to the general population living in mainland France (i.e. excluding Corsica, overseas departments, regions, and communities, and New Caledonia). A quota sampling method was used: sampling wastratified by residential area, size of the urban agglomeration, infant gender, mother's professional activity, occupational and socio-occupational status and adjusted for these different characteristics. This stratification was based on the population characteristics of the 2002 census of the National Institute for Statistics and Economic Research (INSEE, Institut National de la Statistique et des Etudes Economiques).

Beskrivelse

Inclusion Criteria:

  • informed parental consent to participate in the study,
  • absence of intercurrent or chronic disease
  • birth weight above 2.5 kg

Exclusion Criteria:

  • Non compliance withe the study protocol
  • For outcome 3 analysis (intakes), reported weight inconsistent with the child's age (> or <3 SD)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Age groups
Eleven age groups that took into account the previous surveys and the key stages of child development were defined: 15 days to 3 months, 4, 5, 6, 7, 8-9, 10-11, 12- 17, 18-23, 24-29, and 30-35 months.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Age at inclusion
Tidsramme: January to april 2013
months
January to april 2013
Weight at inclusion
Tidsramme: January to april 2013
kg
January to april 2013
Prevalence of socio-demographic condition, feeding practice, consumption energy contribution,
Tidsramme: January to april 2013
frequency in %
January to april 2013
Time of introducing or withdrawing a food
Tidsramme: history of feeding before being included in the survey
months
history of feeding before being included in the survey
Mean over 3 days of Food quantities and macronutrient intake (water, protein, lipid, carbohydrate, fiber)
Tidsramme: January to april 2013
g/d
January to april 2013
Mean over 3 days of Intakes of Linoleic-, alpha linolenic-acids, DHA, ARA, minerals (sodiu, calcium, phosphorus, magnesium, iron, zinc), Vitamin B1,B2, B3, B6, C, E
Tidsramme: January to april 2013
mg/d
January to april 2013
Mean over 3 days of intakes of Vitamin B9, B12, Retinol, Beta-caroten
Tidsramme: January to april 2013
micro g/d
January to april 2013
Vitamin A intake
Tidsramme: January to april 2013
RE(Retinol Equivalent)/d
January to april 2013

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Nutrient intakes per kilogram body weight
Tidsramme: January to april 2013
unit/kg/d
January to april 2013
Comparison with 2005 data
Tidsramme: 2013 vs 2005
p value
2013 vs 2005

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Gabriel TAVOULARIS, Engineer,MSc, CREDOC
  • Hovedetterforsker: Yves EMERY, MSc, TNS Sofres
  • Hovedetterforsker: Jean-Pierre CHOURAQUI, MD, MSc, CHUV Lausanne
  • Studieleder: Magali BOCQUET, Engineer,MSc, Secteur Français des Aliments de l'Enfance

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. januar 2013

Primær fullføring (Faktiske)

21. april 2013

Studiet fullført (Faktiske)

15. februar 2015

Datoer for studieregistrering

Først innsendt

19. oktober 2017

Først innsendt som oppfylte QC-kriteriene

26. oktober 2017

Først lagt ut (Faktiske)

31. oktober 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. oktober 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. oktober 2017

Sist bekreftet

1. oktober 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • Nutri-Bébé SFAE 2013

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

To be shared is the global report of results on each items (food practices, food consumption, nutrients intakes), according to age groups.

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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